Banyan Readies For Pivotal Study Of Molecular Dx For Traumatic Brain Injury
This article was originally published in The Gray Sheet
Executive Summary
Banyan Biomarkers blood-based assay works by detecting the presence of two proteins that only cross the blood-brain barrier if there’s been a brain injury. An IDE was filed July 2 and the firm hopes for PMA approval in 2014.
Alachua, Fla.-based Banyan Biomarkers Inc. expects to hear back from FDA “any day now” about its planned 2,000-patient pivotal trial of its biomarker test for traumatic brain injury, according to CEO Jackson Streeter.
The company filed for an investigational device exemption for the ALERT trial July 2. It hopes to start enrolling both severe and moderate traumatic brain injury (TBI) patients in about 50 centers in multiple countries late this year to support both a CE mark in Europe and a PMA submission to FDA.
The firm’s blood test works by detecting the presence of two proteins (GFAP and UCH-L1) that are found inside the brain and do not cross the blood-brain barrier – unless there’s been an injury. Thus, detecting the proteins in the blood might indicate a TBI.
“I think this is a test that can render an invisible injury visible, and it’s an important thing,” Streeter said. “Right now, too much TBI is relying on [a] self-reported system, and not objective measures, and that’s a void we intend to fill.”
Military Interest
It’s also a void that military leaders are seeking to fill. The ALERT trial will be funded by the Department of Defense under a 2010, $26.3 million contract.
On the battlefield, “We have a lot of blast exposure and a lot of troops who are sitting with concussions, but senior leadership in theater are the last ones [to say anything],” Streeter explained. “[As] one of the field commanders in the Marine Corps told me, ‘What we really need is a thermometer for the brain or a blood test for the brain,’ and that’s what we’re trying to make happen.”
The issue of TBI and concussion in soldiers, athletes and others has attracted significant media scrutiny. And multiple firms are developing device strategies to objectively and quickly detect the injury. (See (Also see "BrainScope Develops Device For TBI/Concussion Assessment" - Medtech Insight, 13 Jun, 2011.).) Last year, the Cleveland Clinic highlighted a concussion management system for athletes as a “top 10” up-and-coming innovation for 2012. (See (Also see "Devices Rank Front And Center In Cleveland Clinic’s 'Top 10' Picks" - Medtech Insight, 10 Oct, 2011.)).
The seriousness of the problem is reflected in the statistics. Citing Centers for Disease Control and Prevention statistics, Streeter says that TBI is associated with approximately 1.7 million emergency room visits annually and 52,000 deaths, as well as an estimated annual cost of $60 billion, and that just accounts for the known injuries. Some go unreported, and some are not properly diagnosed, he stressed at a Capitol Hill event last month sponsored by AdvaMedDx.
Currently, patients with possible TBI are typically evaluated on the Glasgow-Coma Scale and then sent for computer tomography imaging assessment. That is costly – both in time and money – and often not totally accurate, Streeter argues. He cites estimates published in the Journal of Neurotrauma positing that one-third of TBIs are misdiagnosed.
“[As] one of the field commanders in the Marine Corps told me, ‘What we really need is a thermometer for the brain…,’ and that’s what we’re trying to make happen.” –Banyan Biomarkers CEO Jackson Streeter
A patient might be sent home as not having a TBI based on a Glasgow-Coma Scale and CT assessment, but “they can’t go home and pay their taxes, they’re having headaches, they can’t sleep, they have a lot of symptoms,” according to the CEO. Banyan’s test seeks to properly diagnose those patients, he said.
With molecular diagnostics screening, patients can get a preliminary diagnosis for a fraction of the $700 to $1,000 cost of a CT scan; and, because the blood test would be quicker, it could improve throughput for emergency rooms and hospitals, Streeter said. In addition, a patient could avoid the radiation delivered from a CT scan.
“We could eliminate a lot of overuse of CT scans,” Streeter said in the interview. “If [CT scans are] the only tool in the doctor’s toolbox, well that’s the one they have to use. It tends to get overused.”
Streeter says the firm expects data to be published shortly showing that one in five patients could be diverted from the ER or from a CT scan as a result of his company’s test.
Banyan is also conducting a separate study, the GATOR trial, with athletes from the University of Florida, as a way of verifying test performance.
Once the studies wrap up, the firm hopes to get its CE mark soon afterwards, and apply for a PMA, with a hoped-for FDA approval in 2014.
For commercialization, Streeter says it is “likely” that Banyan would seek a partner to get the product to emergency rooms worldwide.
The military may also fuel a next-generation version of the molecular diagnostic, a hand-held test that might be used either in “far-flung” battlefields or by emergency medical technicians.
But multiple challenges need to be overcome to make that a reality, Street acknowledged. “The performance … with different temperatures, with different operating conditions and all that [is an issue.] The engineers think this is all doable, but it’s not there today.”